Phase II clinical trial of personalized peptide vaccination for standard therapy failed Biliary cancer(Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer) patients
Phase 2
- Conditions
- Biliary cancer (Cholangiocell carcinoma,Gallbladder cancer and Biliary tract cancer)
- Registration Number
- JPRN-UMIN000001884
- Lead Sponsor
- Kurume University Cancer Vaccine Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
- Secondary Outcome Measures
Name Time Method 1.Evaluation of long-term prognosis (progression free survival and total survival). 2.Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.